- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00889460
Safety and Tolerability Study of rBet v1 SLIT Tablets
April 28, 2009 updated by: Stallergenes Greer
Phase I Study to re-Investigate the Safety, Tolerability and Pharmacodynamic Effects of SLIT(Tablets) With Recombinant Bet v1 Given in Single Rising Doses and in Multi Dose Regimens to Subjects Sensitised to Birch Pollen
The purpose of this study is to determine the safety and tolerability of several doses of r Bet v1 administered as sub-lingual tablets in subjects sensitised to birch pollen.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Copenhagen, Denmark, 2100
- National University Hospital - Allergy Unit 4222
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- written consent
- Male or female subject from 18 to 60 years old and in general good health
- For woman of child bearing potential:
- Symptoms of birch pollen induced allergic rhinitis for at least the last 2 years.
- Sensitisation to birch pollen as demonstrated with a positive SPT to birch pollen and specific IgE level (birch pollen and r Bet v1) >0.70 kU/L at screening.
- FEV1 at least of 80% of predicted values at screening.
- Subject accepting to comply fully with the protocol.
Exclusion Criteria:
- Past or current disease which as judged by the Investigator, may affect the outcome of this study.
- History of life-threatening asthma,
- Asthma requiring daily treatment (whatever the pharmaceutical class).
- Pregnant or lactating woman.
- Subject being treated with inhaled steroids within 4 weeks prior to screening visit or within 12 weeks prior to screening visit.
- Subject who previously received desensitisation treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder) or who plan to start desensitisation treatment during this study.
- Symptoms during the treatment phase due to a sensitivity to a second allergen.
- Subjects treated with ongoing immunotherapy with another allergen
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1
Placebo group
|
Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.
|
Experimental: 2
rBet v 1 tablets
|
Two tablets (1 placebo + 1 rBet v 1 or 2 rBet v 1) were administered every day over 2 weeks with a 2-day break for the week-end.
Administered doses ranged from 12.5 to 100 µg rBet v 1.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Local tolerability
Time Frame: Assessed every day over 2 weeks
|
Assessed every day over 2 weeks
|
Global safety
Time Frame: Assessed every day over 2 weeks
|
Assessed every day over 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Immunological markers (IgE and IgG4)
Time Frame: Between selection and follow-up visit (up to 18 weeks)
|
Between selection and follow-up visit (up to 18 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Hans-Jorgen MALLING, Pr. MD, National University Hospital - Copenhagen - DENMARK
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- L. Winther, L.K. Poulsen, B. Robin, M. Mélac, H. Malling Safety and Tolerability of Recombinant Bet v 1 (rBet v 1) Tablets in Sublingual Immunotherapy (SLIT) The Journal of Allergy and Clinical Immunology February 2009 (Vol. 123, Issue 2, Page S215)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
April 28, 2009
First Submitted That Met QC Criteria
April 28, 2009
First Posted (Estimate)
April 29, 2009
Study Record Updates
Last Update Posted (Estimate)
April 29, 2009
Last Update Submitted That Met QC Criteria
April 28, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VO58.07 DK
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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